FDA Approves Biogen’s ELOCTATE™ for Hemophilia A

PrintFriendly

FDA Approves Biogen’s ELOCTATE™ for Hemophilia A

June 11, 2014

The US Food and Drug Administration (FDA) has approved Biogen Idec’s ELOCTATE™ for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A (factor VIII deficiency). ELOCTATE™ is a recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy designed to keep the infused clotting factor circulating in the body longer, stretching the time between infusions.

According to a Biogen press release, ELOCTATE™ is the only treatment for hemophilia A to reduce the frequency of prophylactic infusions to every three to five days, preventing bleeds. This is in contrast to the typical three times weekly infusion regimen for people with severe hemophilia A. The FDA approval comes in light of clinical trials in which the product was demonstrated to be safe and effective for both routine prophylactic therapy and to treat acute bleeding episodes.

“The proven ability of ELOCTATE to provide protection from bleeding episodes with prolonged circulation marks the first significant hemophilia A treatment advance in more than 20 years,” said George A. Scangos, PhD, chief executive officer of Biogen Idec. “As a company deeply committed to improving the lives of people with hemophilia, we are excited to bring this important innovation to those living with hemophilia A.”